4 Way

Product NDC: 0067-2086
11-digit product format: 000672086
Labeler code: 0067
Product ID: 0067-2086_43684c76-26b5-24c9-e063-6294a90a9b46
Type: HUMAN OTC DRUG
Nonproprietary name: Phenylephrine hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-01-01
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 10 mg/mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	0067-2086		I	Inactivated by FDA		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0067-2086	0067-2086-01	I	Inactivated by FDA		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: 4 Way
Brand name suffix: Fast Acting
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1087043	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a8fc41c7-4425-41b8-b1c6-eb22ac054734	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0067-2086-01	2025-07-29	C162847	48780-1	3b156c62-2e25-fb37-e063-e6dba90a4e07	Drug Facts
0067-2086-01	2025-07-29	C162847	48780-1	3b156c62-2e25-fb37-e063-e6dba90a4e07	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0067-2086-01	4 WayFast Acting	29.6 mL in 1 BOTTLE, SPRAY	SPRAY	29.6		13
0067-2086-01	4 WayFast Acting	1 in 1 CARTON	SPRAY	1		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0067-2086-01	ML - Milliliter	0067-2086	c086c908-628d-4743-84e6-3d43fe57b914	1	2012-07-24
0067-2086-05	ML - Milliliter	0067-2086	69981360-0504-4153-a7f4-eb82aa864002	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	4 WAY FAST ACTING (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [NOVARTIS CONSUMER HEALTH, INC.]	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	4 WAY FAST ACTING (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [NOVARTIS CONSUMER HEALTH, INC.]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	4 WAY FAST ACTING (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [NOVARTIS CONSUMER HEALTH, INC.]	2
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	4 WAY FAST ACTING (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [NOVARTIS CONSUMER HEALTH, INC.]	2
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	4 WAY FAST ACTING (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [NOVARTIS CONSUMER HEALTH, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	4 WAY FAST ACTING (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [NOVARTIS CONSUMER HEALTH, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-2086	4 WAY FAST ACTING (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [HALEON US HOLDINGS LLC]	11	Current NDC, Legacy NDC, 2 package rows	20240912_a8fc41c7-4425-41b8-b1c6-eb22ac054734.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WALMART DAYTIME AND NIGHTTIME MS SEVERE RELIEF VALUE PACK	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL	WAL-MART STORES INC	888bd90a-a059-4814-bd65-6b735ecfaf3a	2026-08-31	Warnings	Exact identifier application number: M012
Severe Cold and Flu Daytime and Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger	49a98411-aa5a-6de3-e063-6294a90a148f	2026-08-31	Warnings	Exact identifier application number: M012
equate daytime nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDE	Sixarp, LLC	5a5a6917-9fb5-e6ca-e063-6394a90af9dc	2026-08-31	Warnings	Exact identifier application number: M012
Zicam Intense Sinus Relief	OXYMETAZOLINE HYDROCHLORIDE	Church & Dwight Co., Inc.	d916f7ff-84b7-57ef-e053-2995a90a3efa	2026-08-31	Warnings	Exact identifier application number: M012
Afrin Original Nasal	OXYMETAZOLINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc.	ecfa14b8-a3f3-4569-b489-c9e1a51cf09e	2026-08-31	Warnings	Exact identifier application number: M012
Dextromethorphan HBr	DEXTROMETHORPHAN HBR	BIONPHARMA INC.	5a5dde85-8785-8149-e063-6294a90a4d57	2026-08-31	Warnings	Exact identifier application number: M012
Equate Nasal	OXYMETAZOLINE HCL	Sixarp, LLC	5a5e2458-bab0-4931-e063-6394a90ad606	2026-08-31	Warnings	Exact identifier application number: M012
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEF	DEXTROMETHORPHAN HYDROBROMIDE AND HEXYLRESORCINOL	Reckitt Benckiser LLC	8d670d91-9e22-45b9-b568-5b62c2133d32	2026-08-31	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Multi Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	e85b4c2a-d4e0-452c-9a08-fcc0ff6eaa21	2026-08-31	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	67849e09-2056-4013-98b1-d003ed3250a2	2026-08-31	Warnings	Exact identifier application number: M012
MAX Tussin Mucus and Chest Congestion Sugar Free	GUAIFENESIN	Akron Pharma Inc.	3b023b91-e703-4599-9864-96d8c328b45c	2026-08-31	Warnings	Exact identifier application number: M012
MAX Tussin Mucus and Chest Congestion	GUAIFENESIN	Akron Pharma Inc.	ac874a31-5556-4669-937f-dcb52aaecd8a	2026-08-31	Warnings	Exact identifier application number: M012
MAX Tussin Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Akron Pharma Inc.	e0ce4287-bfa1-4413-97c8-4fe2e39bda36	2026-08-31	Warnings	Exact identifier application number: M012
Acetaminophen PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	United Natural Foods, Inc. dba UNFI	24173e77-92ec-4a87-a471-d6867837c180	2026-08-31	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	69af44c2-390c-4223-889a-d5555aef5778	2026-08-28	Warnings	Exact identifier application number: M012
Tussin DM Daytime	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	432d4833-2eaf-4f7c-b6b4-41043a6b7e2a	2026-08-28	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Your Military Exchanges	13fcc43c-bdda-4b65-b6d7-23b39e683651	2026-08-28	Warnings, Adverse reactions	Exact identifier application number: M012
Multi-Symptom Allergy	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Walgreen Company	5170c450-989d-44fa-ab38-86c78feae3b6	2026-08-28	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreens	54cbbc5f-908b-47b2-b37f-3646354d3568	2026-08-27	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Hyvee Inc	4e578c7a-88d4-e4cd-e063-6394a90aac44	2026-08-27	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1087043	phenylephrine HCl 1 % Nasal Spray	PSN	a8fc41c7-4425-41b8-b1c6-eb22ac054734	13
1087043	phenylephrine hydrochloride 10 MG/ML Nasal Spray	SCD	a8fc41c7-4425-41b8-b1c6-eb22ac054734	13
1087043	phenylephrine hydrochloride 1 % Nasal Spray	SY	a8fc41c7-4425-41b8-b1c6-eb22ac054734	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0067-2086-01	00067208601	1 BOTTLE, SPRAY in 1 CARTON (0067-2086-01) / 29.6 mL in 1 BOTTLE, SPRAY	2010-01-01	0000-00-00	No	No	Current